FDA Medical Device Recalls (openFDA)
Medela Inc. EF Division: - NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile) - TL-INT-60 60ml Nutrio Enteral Feeding Syringe with Twistlok adapter (sterile) - INT-60 60mL Nutrio Intopo Enteral Feeding Syringe (sterile) - NGF-60 60ml Nutrio GraviFeed Syringe (sterile) The Enteral Syringe consists of a calibrated hollow cylindrical body and movable plunger. At the tip of the barrel is an oral lock connector. Product is considered sterile.
- Recall number
- Z-1262-2015
- Recalling firm
- Medela Inc. EF Division
- Product
- - NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile) - TL-INT-60 60ml Nutrio Enteral Feeding Syringe with Twistlok adapter (sterile) - INT-60 60mL Nutrio Intopo Enteral Feeding Syringe (sterile) - NGF-60 60ml Nutrio GraviFeed Syringe (sterile) The Enteral Syringe consists of a calibrated hollow cylindrical body and movable plunger. At the tip of the barrel is an oral lock connector. Product is considered sterile.
- Status
- Terminated
- Initiated
- 2015-02-13
- Posted
- 2015-03-11
- Terminated
- 2015-11-09
- Reason
- The firm is recalling sterile enteral feeding syringes due to determining that the sterility of the affected products may be compromised as a result of a potential breach in packaging.
- Root cause
- Packaging
- Action
- Medela sent a Device Recall letter dated February 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Requested Action of Distributors: 1. Stop sale and distribution of product with affected lot numbers. 2. Conduct a physical count and record the data on the Product Inventory Form included with the letter. 3. Return the Product Inventory Form via fax to 800-995-7867 or e-mail it to syringe@medela.com. The firm should contain a contact name and signature. 4. If have the affected product in stock, Medela Customer Service will issue a RMA and schedule a pick-up of the affected product. Contact will be made to ensure product is ready. For further questions please call (888) 399-2455.
- Quantity
- 1,959,187
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- NTL-30 G0556, G0561, G0572, G0585, G0593, G0601, G0610, G0614, G0622, G0634, G0644, G0649, G0653, G0662, G0667, G0672, G0683, G0684, G0685, G0698, G0705, G0708, G0711, G0712, G0714, G0716, G0723, G0719, G0726, G0734, G0744, G0750, G0752, G0760 NTL-60 G0554, G0566, G0578, G0594, G0598, G0612, G0615, G0623, G0626, G0636, G0639, G0650, G0657, G0658, G0659, G0665, G0668, G0670, G0671, G0673, G0679, G0680, G0686, G0687, G0691, G0699, G0703, G0706, G0709, G0715, G0722, G0725, G0729, G0735, G0739, G0741, G0745, G0751, G0756, G0761 TL-INT-60 G0563, G0565, G0577, G0663, G0701, G0710, G0713, G0733, G0737, G0753 INT-60 G0555, G0567, G0575, G0587, G0591, G0603, G0620, G0638, G0640, G0648, G0664, G0690, G0718, G0746 NGF-60 G0550, G0560, G0568, G0576, G0592, G0609, G0628, G0646, G0655, G0675, G0688, G0697, G0707, G0724, G0730, G0728, G0743, G0754
- 510(k) numbers
- ["K092986"]
- PMA numbers
- not on file
- Product code
- FMF
- Firm FEI
- 1419937
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28